Background Malnutrition, which is associated with increased medical complications in older hospitalized patients, can be attenuated by providing nutritional supplements. Objective This study evaluates the cost effectiveness of a specialized oral nutritional supplement (ONS) in malnourished older hospitalized patients. Methods We conducted an economic evaluation alongside a multicenter, randomized, controlled clinical trial (NOURISH Study). The target population was malnourished older hospitalized patients in the USA. We used 90-day (base case) and lifetime (sensitivity analysis) time horizons. The study compared a nutrient-dense ONS, containing high protein and b-hydroxy-b-methylbutyrate to placebo. Outcomes included health-care costs, measured as the product of resource use and per unit cost; quality-adjusted life-years (QALYs) (90-day time horizon); life-years (LYs) saved (lifetime time horizon); and the incremental cost-effectiveness ratio (ICER). All costs were inflated to 2015 US dollars. Results In the base-case analysis, 90-day treatment group costs averaged US$22,506 per person, compared to US$22,133 for the control group. Treatment group patients gained 0.011 more QALYs than control group subjects, reflecting the treatment group's significantly greater probability of survival through 90 days' follow-up, as reported by the clinical trial. Hence, the 90-day follow-up period ICER was US$33,818/QALY. Assuming a lifetime time horizon, estimated treatment group life expectancy exceeded control group life expectancy by 0.71 years. Hence, the lifetime ICER was US$524/LY. The follow-up period for the trial was relatively short. Some of the patients were lost to follow-up, thus reducing collection of health-care utilization data during the clinical trial. Conclusion Our findings suggest that the investigative ONS cost-effectively extends the lives of malnourished hospitalized patients.

Objectives: Combinations of existing therapies are increasingly being developed and marketed across many indications. Whilst they promise substantial clinical benefits, dual-branded therapies may have substantial financial impacts. Obtaining positive HTA approvals and public reimbursement may be a major challenge, which may be amplified if each monotherapy is marketed by a different company. We evaluated whether combination therapies developed by one manufacturer had faster and/or better outcomes than those where each constituent was developed by a separate manufacturer and whether this varied by different HTA archetypes. Methods: ECapproved combination products, comprising at least one on-patent therapy marketed under a separate brand were identified (01/01/2015-31/12/2018) and the number of manufacturers identified. Corresponding HTA reports were identified from G-BA, HAS, SMC, and NCPE websites and relevant data extracted. Results: 114 HTA assessments across 34 combination products:indications were identified (same manufacturer: 58 assessments, two manufacturers: 56 assessments). For clinicaleffectiveness HTA bodies (G-BA and HAS), the rates of positive recommendations (defined as: any additional benefit or ASMR I-III) was similar for combination therapies developed by one vs. two manufacturers (32% vs. 40%). Whereas, for costeffectiveness HTA bodies (NICE, SMC, and NCPE), combination therapies developed by one manufacturer received numerically higher rates of positive recommendations (defined as: "full or optimized/conditional") than those involving two manufacturers (80% vs. 58%). However, there were no corresponding differences in the median time from EC-approval to positive recommendation (5.5 vs. 5.0 months). Conclusions: HTA bodies assessing cost-effectiveness were more likely to issue positive recommendations for dual-branded treatments if each constituent monotherapy was marketed by one company versus two companies. A single company may have more flexibility in its price setting, facilitating higher HTA recommendation rates. Although time to positive HTA decisions were similar, this may not reflect time to launch in some jurisdictions, due to additional time required for pricing negotiations.

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Objectives: Approximately 33% of stroke survivors suffer depression and depression is associated with disability, poor quality of life and mortality. However, assessments of association with healthcare expenditures among stroke survivors were not found. We examined association between depression and healthcare expenditures among stroke survivors. Methods: A retrospective cohort study was conducted using pooled data of 2-year panels from the 2012 through 2016 Medical Expenditure Panel Survey. The panel year-one was used to identify stroke survivors, depression diagnosis and baseline characteristics. The panel year-two was the follow-up period. Inclusion criteria were being 18 years old or older, and stroke diagnosis. Exclusion criteria were institutionalization or death. Stroke was identified based on having ICD-9 diagnosis codes (430 -438), or ever being told by a healthcare provider they had a stroke. Depression was identified based on ICD-9 diagnosis codes (296, 300, 309 or 311) only, since there was no self-report of depression variable in the data. In-patient, outpatient, emergency room, prescription medicines and total healthcare expenditures were examined in panel year-two. Associations between depression and each expenditure category were estimated using a two-part Logit GLM model in STATA, to account for excess zeros and adjusting for age, sex, race, education, marital status, employment status, insurance type, region, income, perceived health, smoking status and comorbidity with an alpha of 0.05 for significance. Results: The final sample (unweighted N = 1,498) was mostly female (58%) and non-Hispanic whites (48%); and 30% (95% CI = 27.9% -32.6%) had depression. The mean (6 standard deviation) age was 64 (6 14.4) years. Depression was associated with an average

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